FDA.reportPublic FDA data

SPIRO

Primary DI
07350061231060
Brand
SPIRO
Company
Fogless International AB
Model
705
Catalog number
705-10
Device description
SPIRO Tweezers
Published
2018-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350061231077PackageGS15In Commercial Distribution
07350061231060PrimaryGS10
07350061231312Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350061231077073500612310777350061231077
07350061231060073500612310607350061231060
07350061231312073500612313127350061231312

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, tweezers-like, reusableA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. This is a reusable device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dark and dry environment at normal indoor room temperature

Contacts#

Phone, Email table
PhoneEmail
+4636144100mail@fogless.se

Regulatory Flags#

DUNS number
356432815
Device count
2
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350061231220SPIRO730730-2K2018-03-31
07350061230353SPIROXXX2023-09-21
07350061231008SPIRO702702-2K; 702-5K;2018-03-31
07350061231046SPIRO703703-2K2018-03-31
07350061231121SPIRO710710-1K; 710-2K; 710-5K2018-03-31
07350061231152SPIRO710R710R-1K; 710R-2K; 710R-5K2018-03-31
07350061231183SPIRO711711-1K; 711-2K; 711-5K;2018-03-31
07350061231268SPIRO760760-1K; 760-1KF2018-03-31
07350061231350SPIRO 740740-25K; 740-100K2018-03-31
07350061231084SPIRO707707-102018-03-31
07350061231107SPIRO708708-102018-03-31
07350061231091SPIRO707707-102018-03-31
07350061231114SPIRO708708-102018-03-31
07350061231237SPIRO730730-102018-03-31
07350061231077SPIRO705705-102018-03-31
07350061231282SPIRO7707702018-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435448MillenniumAvalign Technologies, Inc.GEN2026-10-19
00840329838669N/ABLACK & BLACK SURGICAL, INC.GEN2026-10-15
00190776435011MillenniumAvalign Technologies, Inc.GEN2026-10-14
00190776435035MillenniumAvalign Technologies, Inc.GEN2026-10-14
00190776434816MillenniumAvalign Technologies, Inc.GEN2026-10-13
00190776434779MillenniumAvalign Technologies, Inc.GEN2026-10-12
04058749012842NAFehling Instruments GmbH & Co. KGGEN2026-10-12
00190776434175MillenniumAvalign Technologies, Inc.GEN2026-10-09
00198506095801ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095818ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095825ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095832ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00840314252449gSourceGSOURCE LLCGEN2026-10-09
00190776436605MilleniumAvalign Technologies, Inc.GEN2026-10-08
00190776433604MillenniumAvalign Technologies, Inc.GEN2026-10-07
00190776434380MillenniumAvalign Technologies, Inc.GEN2026-10-07
B382SD6713210Surgical DirectSurgical Direct, Inc.GEN2026-10-07
B382SD6713290Surgical DirectSurgical Direct, Inc.GEN2026-10-07
B382SD6520450Surgical DirectSurgical Direct, Inc.GEN2026-10-06
B382SD6562120Surgical DirectSurgical Direct, Inc.GEN2026-10-06
00190776433048MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433130MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433147MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433178MillenniumAvalign Technologies, Inc.GEN2026-10-01
B382SD8160490Surgical DirectSurgical Direct, Inc.GEN2026-09-30
00190776432829MillenniumAvalign Technologies, Inc.GEN2026-09-29
00190776432898MillenniumAvalign Technologies, Inc.GEN2026-09-29
B382SD4937851340Surgical DirectSurgical Direct, Inc.GEN2026-09-29
00190776432522MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432553MillenniumAvalign Technologies, Inc.GEN2026-09-28